The purpose of this study is to evaluate the safety and efficacy of stereotactic transplantation of hAESCs for Parkinson's disease.
The study plans to recruit 3 participants with Parkinson's disease . Using stereotactic technology, hAESCs will be accurately transplanted into the lateral ventricle. Therapeutic effectiveness and safety of hAESCs on PD will be evaluated. hAESCs are derived from placental amnion donated after cesarean section in healthy women. hAESCs is developed from the epiblast as early as 8 days after fertilization, recent reports indicate that hAESCs have some characteristics of neural stem cell. These cells are able to differentiate into dopaminergic neurons and secrete dopamine and various neurotrophic factors. These HAESCs could be seen as one of the best potential stem cell source for treating Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Stereotactic transplantation of hAESCs for participants with PD.
WU Jingwen
Shanghai, Shanghai Municipality, China
Number of Participants with adverse event and serious adverse event
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.
Time frame: 12 months
Changes in Unified Parkinson's Disease Rating Scale (UPDRS) in ON and OFF state
UPDRS is used for evaluating the impairment and disability associated with Parkinson's Disease (PD). It consists of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications. The UPDRS score ranges from 0 to 199, with higher score indicating greater disability.
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Hoehn and Yahr scale
Hoehn and Yahr scale is used to provide a general estimate of clinical function of PD patients, combining functional deficits (disability) and objective signs (impairment). The Hoehn and Yahr score ranges from 0 to 5, with higher score indicating higher dysfunction of PD patients.
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in Parkinson's Disease Questionnaire (PDQ-39)
PDQ-39 provides the evidence of the quality of life of a PD patient. The higher the score, the lower the quality of life of PD patients.
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
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Changes in the Schwab and England score
The Schwab and England scale develop a scale that describes the capacity of daily living shown by a PD patient. It measures the following three areas: dependence, abilities, and awareness. The Schwab and England scores range from 0% to 100%, with higher scores indicating greater healthy status.
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Levodopa equivalent daily dose
Differences in daily dosage of levodopamine
Time frame: day 0, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month, 9 month and 12 month.
Cranial doparmin transporter measured by positron emission tomography(PET)-magnetic resonance Imaging(MRI)
Changes of cranial expression of dopamine transporter investigated by PET-MR
Time frame: 4 month, 6 month
Glucose metabolism measured by 18F-Fluoro-2-deoxy-glucose (FDG) PET scan
Changes in cranial glucose metabolism investigated by PET-MR
Time frame: 4 month, 6 month
Differences in biochemical indicators of cerebrospinal fluid
Cerebrospinal fluid indicator tests include biochemical indicators and the following parameters: Dopamine (DA), high vanillic acid (HVA), 5-hydroxytryptamine (5-HT), 5-hydroxyindoleacetic acid (5-HIAA), norepinephrine (MHPG), α synuclein (α-synuclein), amyloid deposition (Aβ42), Tau protein (Tau) Protein, Neurofilament light (NF-L), and yKL-40 (YKL-40).
Time frame: day 0, 1 month, 2 month, 3 month, 4 month,5 month,6 month, 9 month and 12 month.